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First Paediatric Use Marketing Authorisation Granted

Submitted by msb on Wed, 14/09/2011 - 13:11
Published date: 
14/09/2011

The European Commission has granted the first ever children’s medicine to hold a new Paediatric Use Marketing Authorisation (PUMA). The medicine called Buccolam is now specifically licensed to treat convulsions and epileptic seizures in children.
A PUMA will cover the appropriate formulation for the paediatric population. Once granted, the PUMA will benefit from ten years of market protection as a reward for the development.

This change is a leap forward in helping to improve the safety, quality and availability of children’s medicines in the EU.

The development of medicines for children also require a Paediatric Investigation Plan (PIP) which must discuss all paediatric subsets to be agreed by the Paediatric Committee.

If you require assistance with a Paediatric Use Marketing Authorisation or Paediatric Investigation Plan please contact us at enquiries@wainwrightassociates.co.uk or telephone +44 (0)1628 530554.

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